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Local Subcutaneous Gentamicin for Prevention of Surgical Site Infection After Elective Cesarean Section

NCT ID: NCT07311395

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2026-01-07

Brief Summary

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The goal of this clinical trial is to evaluate whether local subcutaneous administration of gentamicin reduces the incidence of surgical site infection (SSI) following elective cesarean section. The study will also assess the safety of local gentamicin administration. The main questions this study aims to answer are:

* Does local subcutaneous administration of gentamicin reduce the rate of superficial and deep surgical site infections within 30 days after elective cesarean delivery?
* Are there differences between groups in postoperative complications, including wound healing, fever, need for additional antibiotic treatment, or hospital readmission?

Researchers will compare women who receive local subcutaneous gentamicin at the surgical site in addition to standard antibiotic prophylaxis to women who receive standard antibiotic prophylaxis alone.

Participants will:

* Undergo an elective cesarean section according to standard clinical practice
* Receive either local subcutaneous gentamicin administration or no local antibiotic administration, in addition to standard systemic antibiotic prophylaxis
* Be followed clinically for signs of surgical site infection and other postoperative complications during hospitalization and at follow-up visits up to 30 days after surgery

Detailed Description

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Conditions

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Local subcutaneous gentamicin

Group Type EXPERIMENTAL

Gentamicin

Intervention Type DRUG

Participants receive a single local subcutaneous administration of gentamicin at the surgical site during elective cesarean section, in addition to standard systemic antibiotic prophylaxis, to reduce postoperative surgical site infection.

Standard antibiotc prophylaxis

Group Type ACTIVE_COMPARATOR

Standard antibiotic prophylaxis

Intervention Type DRUG

Participants receive standard systemic antibiotic prophylaxis according to institutional protocol.

Interventions

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Gentamicin

Participants receive a single local subcutaneous administration of gentamicin at the surgical site during elective cesarean section, in addition to standard systemic antibiotic prophylaxis, to reduce postoperative surgical site infection.

Intervention Type DRUG

Standard antibiotic prophylaxis

Participants receive standard systemic antibiotic prophylaxis according to institutional protocol.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women aged 18 years and older. Undergoing elective cesarean section. Gestational age \>= 24 weeks. Planned postoperative follow-up of 30 days. Eligible for standard antibiotic prophylaxis according to institutional protocol.

Able to provide informed consent.

Exclusion Criteria

* Known allergy of hypersensitivity to aminoglycosides. Known allergy of hypersensitivity to systemic antibiotic prophylaxis agents. Current or planned use of immunomodulatory or immunosuppressive therapy. Requirement for therapeutic ( non- prophylactic) antibiotic treatment at the time of surgery.

Active infection or clinical condition requiring antibiotic treatment. Inability or unwillingness to comply with study procedures or follow-up.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Nadir Ganem

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Western Galilee Hospital-Nahariya

Nahariya, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Principal Investigator

Role: primary

Other Identifiers

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0177-25-NHR

Identifier Type: -

Identifier Source: org_study_id